Drug development steps

Health authorities worldwide have fixed purity requirements for active pharmaceutical ingredients (APIs). When applied to chiral drugs, this implies that, if one enantiomer is chosen to be developed and marketed as an API, the counterpart isomer will be considered an impurity. The rule affects new chemical entities (NCEs) and chiral dmgs previously commercialized as a racemic mixture chiral switches). Therefore, techniques to perform the analytical control of the enantiomeric composition, at any of the drug development steps, together with processes to produce enantiomeric compounds with the desired enantiomeric purity, are essential in this domain. Liquid chromatography using chiral stationary phases (CSPs) is applied at two levels, analysis and production of enantiomerically pure compounds. At present, it can be considered the most universal technique for enantiomer separation. 

The New Drug Development Process Steps from Test Tube to New Drug Application Review, [Internet]. URL http //www.fda.gov/cder/handbook/ develop, htm, accessed 7-29-2000. 

Drug development is ideally a logical, step-wise procedure in which information from small early studies is used to support and plan later larger, more definitive studies. To develop new drugs efficiently, it is essential to identify characteristics of the investigational drugs in the early stages of development and to plan an appropriate development based on this profile. 

Examples of PAT applications to drug development are a crystallization process optimization from laboratory to industrial scale [72] optimization of manufacturing steps in pharmaceuticals [70]... 

Recently, the focus has been placed especially on the chromatographic interface as a means for improving bioanalytical efficiency and novel advantages on samples preparation (and separation) related to the fact that they are generally the rate limiting steps in drug development process. 

Analytical methods are important not only in the development and manufacture of commercial biopharmaceutical drugs, they also play a vital role in the whole drug development life cycle. Drug discovery and preclinical research require development and application of analytical methodologies to support identification, quantitation, and characterization of lead molecules. It is difficult to perform a comparative potency assay on lead molecules if one does not know how much of each is going into the assay or how pure the molecule is. Analytical methods are typically developed, qualified, and validated in step with the clinical... 

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